Table 6 Most frequent (serious) adverse events
Fingolimod 0.5 mg N = 3951 | ||
|---|---|---|
Number of patients, n (%) | Number of events, n | |
Summary of adverse events | ||
Any adverse event | 1350 (34.17) | 2207 |
Any serious adverse event | 117 (2.96) | 152 |
Any adverse event leading to discontinuation of study drug | 38 (0.96) | 69 |
Common adverse events (>1% in SOC/PT) | ||
Nervous system disorders | 403 (10.20) | 464 |
Headache | 199 (5.04) | 205 |
Dizziness | 72 (1.82) | 73 |
MS relapse | 58 (1.47) | 59 |
General disorders and administration site conditions | 240 (6.07) | 265 |
Fatigue | 135 (3.42) | 138 |
Cardiac disorders | 231 (5.85) | 263 |
AV block first degree | 69 (1.75) | 70 |
AV block second degree | 65 (1.65) | 67 |
Bradycardia | 45 (1.14) | 45 |
Gastrointestinal disorders | 217 (5.49) | 246 |
Nausea | 91 (2.30) | 92 |
Diarrhoea | 52 (1.32) | 52 |
Infections and infestations | 170 (4.30) | 178 |
Nasopharyngitis | 78 (1.97) | 78 |
Investigations | 130 (3.29) | 150 |
Blood and lymphatic disorders | 115 (2.91) | 140 |
Lymphopenia | 73 (1.85) | 74 |
Musculoskeletal and connective tissue disorders | 94 (2.38) | 102 |
Skin and subcutaneous tissue disorders | 66 (1.67) | 69 |
Psychiatric disorders | 61 (1.54) | 63 |
Vascular disorders | 60 (1.52) | 61 |
Respiratory, thoracic and mediastinal disorders | 59 (1.49) | 60 |
Ear and labyrinth disorders | 47 (1.19) | 49 |
Common serious adverse events (>0.1% in SOC/PT) | ||
Cardiac disorders | 52 (1.32) | 65 |
AV block second-degree | 31 (0.78) | 33 |
Bradycardia | 15 (0.38) | 15 |
AV block | 5 (0.13) | 5 |
Nervous system disorders | 33 (0.84) | 36 |
MS relapse | 18 (0.46) | 19 |
General disorders and administration site conditions | 7 (0.18) | 7 |
Infections and infestations | 7 (0.18) | 7 |
Gastrointestinal disorders | 6 (0.15) | 8 |
Vascular disorders | 6 (0.15) | 6 |
Symptoms that might have resulted from cardiac events (at Visit 2) | ||
Fatigue | 68 (1.72) | |
Dizziness | 26 (0.66) | |
Chest discomfort | 8 (0.20) | |
Vertigo | 7 (0.18) | |
Palpitations | 7 (0.18) | |
Dyspnea | 5 (0.13) | |
Angina pectoris | 3 (0.08) | |
Blurred vision | 2 (0.05) | |
Syncope | 1 (0.03) | |
Exertional dyspnoe | 1 (0.03) | |